Over-the-Counter Treatments for Joint Pain and Women's Health Propel Company into New Markets

Source: Streetwise Reports (8/9/17)

With the launch of its over-the-counter combination treatment for joint pain and new licensing agreements for feminine lubrication product Zestra, this San Diego-based company is expanding both its therapeutic and international reach.

Source: Innovus Pharma

Commenting on recent announcements from Innovus Pharmaceuticals Inc. (INNV:OTCQB), which markets over-the-counter (OTC) products addressing men's and women's health, as well as respiratory and other ailments, Jay Albany, senior analyst with SeeThru Equity, noted the company "has been developing a promising growth engine in what appears to be a replicable process of identifying promising OTC products that target large markets—and then leveraging its Beyond Human sales platform and online marketing expertise to drive high gross margin sales."

On July 20 Innovus announced "the launch of its first proprietary combination of an OTC monograph drug and a supplement: Apeaz, a cream for the relief of arthritis pain, and ArthriVarx, a nutritional supplement designed to promote and maximize joint health."

In combination with ArthriVarx, Apeaz is intended to address the large joint pain market. Apeaz is "the only OTC monograph drug published and commercialized to reduce all signs and symptoms of arthritis in a collagen induced mouse model," according to the company. Active ingredients in the cream include "methyl-sulfonyl methane (MSM) and glucosamine sulfate known to help damaged cartilage for stronger and more pressure resistant joints," the company stated. ArthriVarx, "a joint supplement designed to maximize the health of joints," contains andrographolides paniculata and hyaluronic acid.

"We are intrigued by [the] Apeaz and ArthriVarx announcement, which adds a new and large market opportunity for Innovus that is a good match for its existing portfolio," said Albany. "We are keen to see how quickly Innovus is able to penetrate the $850mn market for arthritis and joint pain with a commercial strategy that combines an OTC drug with a synergistic nutritional supplement."

With regard to Zestra, on July 20 the company announced that its partner, Luminaire, had secured approval to market the feminine lubricant in Australia. In May, Innovus signed a licensing agreement with Luminaire, an Australian firm, to market Zestra in Australia, New Zealand and the Philippines.

And on July 26, Innovus announced an agreement with Densmore Pharmaceutical International, based in Monaco, "for the commercialization of Zestra in Singapore and Vietnam."

The licensing agreements and approvals for Zestra further expand the international distribution of the product. According to the July 26 Innovus press release, Zestra is "currently approved to be commercialized in 34 countries of the world, namely, in Canada, the 28 countries of the European Union, Australia, India, Hong Kong, the United Arab Emirates ('UAE'), South Korea and Morocco. Innovus currently generates revenues from the following markets for Zestra: Canada, Morocco, certain European countries, South Korea and Hong Kong in addition to the United States as its biggest market."

"We expect Zestra for female arousal/interest to be a core driver of the growth for Innovus over the next several months while we await the company's launch of FlutiCare," Albany stated. "Zestra targets what is a billion-dollar female sexual dysfunction market in the US alone. It has already been approved for commercialization in more than 30 countries, and has multiple ongoing partner-based commercialization activities that are commencing now and expected to drive growth for many quarters to come."

The company expects to launch its respiratory product, FlutiCare (fluticasone propionate spray), in Q4/17; its abbreviated new drug application for OTC distribution is currently being considered by the FDA. More recently, Innovus announced it had placed an order for 220,000 units of FlutiCare preparation for the product launch in the U.S.

"The Company is on target with its planned launch in the fourth quarter of 2017 of its FlutiCare product, the third national branded OTC fluticasone propionate nasal spray in the allergic rhinitis market," Innovus stated in an Aug. 9 press release. "The Company ordered one batch of the drug from its partner West-Ward for Q4 2017 and has committed multiple batches for 2018 and 2019 and currently expects to receive over $3.0 million in gross revenues for each batch it sells in the U.S. market."

On July 31, Innovus also announced it had filed a product license application in Canada for over-the-counter sale of Xyralid, "a clinically-proven, lidocaine-based cream for the relief of pain and symptoms caused by hemorrhoids." The review process with Health Canada is expected to take four months.

The company's other OTC products include its Beyond Human testosterone booster; ProstaGorx, a supplement to support prostate health; and Vesele, a supplement intended to "enhance sexual endpoints" for both men and women.

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